Phase 2
Completed N=95
Smoking, Sex Hormones, and Pregnancy
Source: ClinicalTrials.gov NCT01811225 ↗Enrolled (actual)
95
Serious AEs
0.0%
Results posted
Nov 2020
Primary outcomePrimary: Change in Smoking Urges — 5.0; 5.5 score on a scale
Summary
The investigators aim to (1) examine the association between levels of progesterone (Prog), allopregnanolone (Allo), and the estradiol/progesterone (E2/P) ratios with smoking-related symptomatology during ad libitum smoking and (2) determine the association between Prog, Allo, and E2/P with the changes in smoking-related symptomatology and response to nicotine following overnight abstinence
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Smoking Urges |
5.0; 5.5 | — |
| SECONDARY Change in Positive and Negative Affect Scale Following Overnight Abstinence |
26.21; 24.09; 17.01; 15.41 | — |
| SECONDARY Change in Cohen Perceived Stress Scale |
14; 15 | — |
Eligibility Criteria
Inclusion Criteria
- currently taking oral contraceptives
- English fluency
- Ability to provide informed consent
Exclusion Criteria
- use of progestin only contraceptive
- pregnancy
Data sourced from ClinicalTrials.gov (NCT01811225). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.